Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY 44-4400 · 1 trial · 2 indications
• To investigate the pharmacokinetics (PK) including * relative bioavailability of Formulation B of emodepside (BAY 44-4400) in comparison to Formulation A * food-effect on Formulation B of emodepside (BAY 44-4400) If a relevant carry-over is observed in any participant as defined by C0/Cmax \> 5%, corrected Cmax parameters accounting for carry-over will be calculated for all participants in addition.
• To investigate the pharmacokinetics (PK) including - relative bioavailability of Formulation B of emodepside (BAY 44-4400) in comparison to Formulation A \- food-effect on Formulation B of emodepside (BAY 44-4400) If a relevant carry-over is observed in any participant as defined by C0/Cmax \> 5%, corrected AUC parameters accounting for carry-over will be calculated for all participants in addition.
| Arm | Type | Description |
|---|---|---|
| Period 1 Formulation A, fasted | EXPERIMENTAL | All subjects will receive either Formulation A or Formulation B per randomisation scheme as a single dose in fasted state. |
| Period 1 Formulation B, fasted | EXPERIMENTAL | All subjects will receive either Formulation A or Formulation B per randomisation scheme as a single dose in fasted state. |
| Period 2 - Crossover Formulation A, fasted | EXPERIMENTAL | All subjects will receive either Formulation A or Formulation B Cross-over: dependent on what they received in period 1 per randomisation scheme as a single dose in fasted state |
| Period 2 - Crossover Formulation B fasted | EXPERIMENTAL | All subjects will receive either Formulation A or Formulation B Cross-over: dependent on what they received in period 1 per randomisation scheme as a single dose in fasted state |
| Period 3 - no dose adjustment after Period 2 | EXPERIMENTAL | If no dose adjustment was needed after Period 2, all subjects will receive Formulation B in fed state |
| Period 3 - dose adjustment after Period 2, fasted | EXPERIMENTAL | If dose adjustment was needed after period 2, all subjects will receive Formulation B as single dose either in fasted or in fed state |
| Period 3- dose adjustment after Period 2, fed | EXPERIMENTAL | If dose adjustment was needed after period 2, all subjects will receive Formulation B as single dose either in fasted or in fed state |
| Period 4 - crossover following Period 3 (in case of dose adjustment after Period 2), fasted | EXPERIMENTAL | All subjects will receive Formulation B as single dose either in fasted or in fed state depending on if they were in the fasted or fed group in Period 3 |
| Period 4 - crossover following Period 3 (in case of dose adjustment after Period 2), fed | EXPERIMENTAL | All subjects will receive Formulation B as single dose either in fasted or in fed state depending on if they were in the fasted or fed group in Period 3 |
| Name | Type | Description |
|---|---|---|
| BAY 44-4400 | DRUG | Film-coated tablet, oral use |
Inclusion Criteria: * Men aged 18 to 55 years of age inclusive, at the time of signing the informed consent, non-smokers, body mass index within the range of 18.0 - 29.9 kg/m2 (inclusive) at Screening * Women that are not breastfeeding and are of non-childbearing potential aged 18 to 55 years of ag...
BAY 44-4400, also known as emodepside, is an investigational small molecule being studied for the treatment of soil-transmitted helminth infection and onchocerciasis (river blindness). It is currently in Phase 1 clinical development and is not yet approved for any use.
BAY 44-4400 is being developed by Bayer AG, a German pharmaceutical company traded on the OTC market under the ticker BAYRY. The drug is in Phase 1 clinical development for soil-transmitted helminth infection.
BAY 44-4400 is in Phase 1 clinical development. One Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities for any indication.
BAY 44-4400 has one completed Phase 1 trial, NCT06412926, which studied how much emodepside gets absorbed in the blood and how food affects its absorption when given as a new type of tablet to healthy participants in Germany.
Yes, BAY 44-4400 is also known as emodepside. The Phase 1 trial NCT06412926 refers to the drug as emodepside, and it is being studied for soil-transmitted helminth infection and onchocerciasis.